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CLOSEOUT LETTER

GPT Pharmaceuticals Private Ltd MARCS-CMS 590938 —

Reference #:
FEI 3008311641
Product:
Drugs

Recipient:
Recipient Name
Mr. Ashok Adityan
Recipient Title
Managing Director
GPT Pharmaceuticals Private Ltd

11-1, C.I.E.E, Grandhinagar
Balanagar
Hyderabad 500037
India

Issuing Office:
Center for Drug Evaluation and Research | CDER

United States


Dear Mr. Adityan:

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-20-13 dated December 17, 2019.

Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority.

The FDA expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.


Sincerely,
/S/
Lynnsey Renn, Ph.D.
Compliance Officer
Division of Drug Quality II

 
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